DementiaNCT05558839
The Effect of Exercise and Cognitive Training on Community-dwelling Older Adults With Dementia.
A study testing A 12-week weekly sports and cognitive training intervention. in people with Dementia and Exercise, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study aimed to explore the effects of an exercise and cognitive training intervention on the physical fitness, fall, and cognitive functions of community-dwelling older adults with dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- A 12-week weekly sports and cognitive training intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Apr 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The list of dementia cases under the supervision of the Taipei City Government Health Bureau, who are over 65 years of age and have been diagnosed with mild to moderate dementia.
- Those who can participate in sports activities.
- Those who can communicate in both Chinese and Taiwanese, have self-determination ability and can clearly express their wishes.
Who cannot join
- Those who have exercise contraindications due to medical reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise and Cognitive Training on the Physical Fitness, Fall, and Cognition Among Community-dwelling Older Adults With Dementia.
This study aimed to explore the effects of an exercise and cognitive training intervention on the physical fitness, fall, and cognitive functions of community-dwelling older adults with dementia. The exercise and cognitive training intervention of this study promoted physical fitness, reduced chance of falling, and improved the cognitive functions of community-dwelling older adults with dementia. In addition, the score of risk of falling reduced.
Read the detailed description
Taiwan has become an aged society, and its population with dementia increases rapidly. Older adults with dementia have unfavorable balance ability and may lack muscle strength; consequently, their probability of falling is twice as high as that of healthy older adults, and their probability of falling and being hospitalized is three times that for general healthy older adults. Compared to European countries and the United States, Taiwan has limited studies on older adults with dementia regarding effects of exercise and cognitive intervention. To develop an intervention for older adults with dementia that integrates exercise and cognitive training to promote or maintain their physical fitness and cognitive function to reduce their risk of falling is critical.
This study adopted a quasi-experimental study design involving single-group pretest-posttest. The research participants were 41 community older adults with mild or moderate dementia. Participants were recruited from 5 community-based dementia care centers in Taipei City. A 12-week weekly sports and cognitive training intervention was provided to the participants. The training, 2 hours each week, involved one hour of sports training and one hour of cognitive training.
Physiotherapists prescribed and delivered interventions in the exercise arm. Each exercise session began with a 5-minute warm up and stretching, followed by 15-minute Aerobic exercises, 15-minute of resistance training, 10-minute of agility and balance training, and 5-minute of cooling down.
Board game teachers who have more than 5 years of community teaching experience prescribed and delivered interventions in the cognitive arm.
Each cognitive session uses different board games to strengthen training for different cognitive aspects.
Before and after the intervention, data of the participants' functional physical fitness, their scores of the STRATIFY Falls Risk Assessment, and their scores of the Montreal Cognitive Assessment were collected as the outcome indicators. A paired t test was used to analyze the results of the intervention. This study aimed to explore the effects of an exercise and cognitive training intervention on the physical fitness, fall, and cognitive functions of community older adults with dementia.
- Conditions
- Dementia, Exercise, Fall, Cognitive Training
- Being tested
- A 12-week weekly sports and cognitive training intervention.
- Medical subject headings
- Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 12-week weekly sports and cognitive training intervention.Behavioural
A 12-week weekly sports and cognitive training intervention was provided to the participants. The training, 2 hours each week, involved 1 hour of sports training and 1 hour of cognitive training.
| Study group | Role | What they receive |
|---|---|---|
| exercise training | Experimental | Physiotherapists prescribed and delivered interventions in the exercise arm. Each exercise session began with a 5-minute warm up and stretching, followed by 15-minute Aerobic exercises, 15-minute of resistance training, 10-minute of agility and balance training, and 5-minute of cooling down. Receives: Behavioral: A 12-week weekly sports and cognitive training intervention. |
| cognitive training | Experimental | Board game teachers who have more than 5 years of community teaching experience prescribed and delivered interventions in the cognitive arm.
Each cognitive session uses different board games to strengthen training for different cognitive aspects. Receives: Behavioral: A 12-week weekly sports and cognitive training intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional physical fitness
Physiological measurements:
- The 30 second chair stand test is for testing leg strength and endurance in older adults. This requires people to repeatedly stand up from and sit down on a chair for 30 seconds. The number of stands is recorded. This reflects lower body strength.
- The handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles.
- The 8-foot up-and-go test is used to measure balance, agility, and speed while walking or moving.
Measured: 14 weeks (Before and after interventions)
Falls risk assessment
We reported fall risk was assessed with the STRATIFY assessment tool(St. Thomas Risk Assessment Tool in Falling Elderly Inpatients) by questionnaire.
Falls risk assessment tool is used to identify fall risk factors for falls in the elderly and to predict the chance of falling.
This tool comprises five items addressing risk factors: past history of falling, patient agitation, visual impairment, incontinence, transfer and mobility. The STRATIFY score range from 0 to 5 points and the predictive cut off of risk of falling is a score ≥ 2 points.
Measured: 14 weeks (Before and after interventions)
Cognitive Assessment
We reported cognitive assessment was assessed with the Taiwan version of Montreal Cognitive Assessment (MoCA-T) by questionnaire.
The Montreal Cognitive Assessment (MoCA) is a test used by healthcare providers to evaluate people with memory loss or other symptoms of cognitive decline. The MoCA contains 30 questions and takes around 10 to 12 minutes to complete. The MoCA checks different types of cognitive or thinking abilities. These include: orientation, short-term memory/delayed recall, executive function/visuospatial ability, language, abstraction, animal naming, attention, and clock-drawing test. The MoCA test uses a 30-point scale and take only 10 to 12 minutes. to complete. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.
Measured: 14 weeks (Before and after interventions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start6 Apr 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This study adopted a quasi-experimental study design involving single-group pretest-posttest. The research participants were 41 community-dwelling older adults with mild or moderate dementia.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chang Hui-Wen, M.D., Principal investigator, member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558839
- Sponsor's protocol ID
- 2021-02-022B
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise and Cognitive Training on the Physical Fitness, Fall, and Cognition Among Community-dwelling Older Adults With Dementia.
- ClinicalTrials.gov ID
- NCT05558839
- Acronym / sponsor ID
- 2021-02-022B
- Conditions
- Dementia, Exercise, Fall, Cognitive Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to explore the effects of an exercise and cognitive training intervention on the physical fitness, fall, and cognitive functions of community-dwelling older adults with dementia. The exercise and cognitive training intervention of this study promoted physical fitness, reduced chance of falling, and improved the cognitive functions of community-dwelling older adults with dementia. In addition, the score of risk of falling reduced.
Detailed description
Taiwan has become an aged society, and its population with dementia increases rapidly. Older adults with dementia have unfavorable balance ability and may lack muscle strength; consequently, their probability of falling is twice as high as that of healthy older adults, and their probability of falling and being hospitalized is three times that for general healthy older adults. Compared to European countries and the United States, Taiwan has limited studies on older adults with dementia regarding effects of exercise and cognitive intervention. To develop an intervention for older adults with dementia that integrates exercise and cognitive training to promote or maintain their physical fitness and cognitive function to reduce their risk of falling is critical.
This study adopted a quasi-experimental study design involving single-group pretest-posttest. The research participants were 41 community older adults with mild or moderate dementia. Participants were recruited from 5 community-based dementia care centers in Taipei City. A 12-week weekly sports and cognitive training intervention was provided to the participants. The training, 2 hours each week, involved one hour of sports training and one hour of cognitive training.
Physiotherapists prescribed and delivered interventions in the exercise arm. Each exercise session began with a 5-minute warm up and stretching, followed by 15-minute Aerobic exercises, 15-minute of resistance training, 10-minute of agility and balance training, and 5-minute of cooling down.
Board game teachers who have more than 5 years of community teaching experience prescribed and delivered interventions in the cognitive arm.
Each cognitive session uses different board games to strengthen training for different cognitive aspects.
Before and after the intervention, data of the participants' functional physical fitness, their scores of the STRATIFY Falls Risk Assessment, and their scores of the Montreal Cognitive Assessment were collected as the outcome indicators. A paired t test was used to analyze the results of the intervention. This study aimed to explore the effects of an exercise and cognitive training intervention on the physical fitness, fall, and cognitive functions of community older adults with dementia.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study adopted a quasi-experimental study design involving single-group pretest-posttest. The research participants were 41 community-dwelling older adults with mild or moderate dementia.
| Arm | Type | Receives |
|---|---|---|
| exercise training | Experimental | Behavioral: A 12-week weekly sports and cognitive training intervention.Physiotherapists prescribed and delivered interventions in the exercise arm. Each exercise session began with a 5-minute warm up and stretching, followed by 15-minute Aerobic exercises, 15-minute of resistance training, 10-minute of agility and balance training, and 5-minute of cooling down. |
| cognitive training | Experimental | Behavioral: A 12-week weekly sports and cognitive training intervention.Board game teachers who have more than 5 years of community teaching experience prescribed and delivered interventions in the cognitive arm. Each cognitive session uses different board games to strengthen training for different cognitive aspects. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- The list of dementia cases under the supervision of the Taipei City Government Health Bureau, who are over 65 years of age and have been diagnosed with mild to moderate dementia.
- Those who can participate in sports activities.
- Those who can communicate in both Chinese and Taiwanese, have self-determination ability and can clearly express their wishes.
Key exclusion criteria (1 listed)
- Those who have exercise contraindications due to medical reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A 12-week weekly sports and cognitive training intervention.A 12-week weekly sports and cognitive training intervention was provided to the participants. The training, 2 hours each week, involved 1 hour of sports training and 1 hour of cognitive training. | Behavioural | cognitive training, exercise training |
Primary outcome
functional physical fitness
Time frame: 14 weeks (Before and after interventions)
Physiological measurements: * The 30 second chair stand test is for testing leg strength and endurance in older adults. This requires people to repeatedly stand up from and sit down on a chair for 30 seconds. The number of stands is recorded. This reflects lower body strength. * The handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles. * The 8-foot up-and-go test is used to measure balance, agility, and speed while walking or moving.
Falls risk assessment
Time frame: 14 weeks (Before and after interventions)
We reported fall risk was assessed with the STRATIFY assessment tool(St. Thomas Risk Assessment Tool in Falling Elderly Inpatients) by questionnaire. Falls risk assessment tool is used to identify fall risk factors for falls in the elderly and to predict the chance of falling. This tool comprises five items addressing risk factors: past history of falling, patient agitation, visual impairment, incontinence, transfer and mobility. The STRATIFY score range from 0 to 5 points and the predictive cut off of risk of falling is a score ≥ 2 points.
Cognitive Assessment
Time frame: 14 weeks (Before and after interventions)
We reported cognitive assessment was assessed with the Taiwan version of Montreal Cognitive Assessment (MoCA-T) by questionnaire. The Montreal Cognitive Assessment (MoCA) is a test used by healthcare providers to evaluate people with memory loss or other symptoms of cognitive decline. The MoCA contains 30 questions and takes around 10 to 12 minutes to complete. The MoCA checks different types of cognitive or thinking abilities. These include: orientation, short-term memory/delayed recall, executive function/visuospatial ability, language, abstraction, animal naming, attention, and clock-drawing test. The MoCA test uses a 30-point scale and take only 10 to 12 minutes. to complete. Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Hui-Wen, M.D. principal investigator
member
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 12-week weekly sports and cognitive training intervention. in people with Dementia and Exercise, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional physical fitness (time frame: 14 weeks (Before and after interventions)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.